Yoga therapy on elderly patients with fear of fall: an open-label randomised controlled trial (YOFEAR trial).

INTRODUCTION: Fear of fall is experienced by the elderly irrespective of the presence or absence of history of fall. Falls contribute to injuries that culminate in hospitalisation that incur unwarranted medical expenses. Yoga is unique to Indian cultural practices, with a potential to enhance proprioception. It increases self-body awareness, ultimately improving the balancing capacity of older adults. Thus, the objective of this study is to compare the effect of yoga therapy in the study and control groups at 12 weeks from the baseline.

METHODS AND ANALYSIS: This study is designed as an open-label, randomised controlled trial (1:1) with a sample size of 62 elderly patients more than or equal to 60 years of age. Participation of either sex, male or female with a fear of fall will be considered. Two randomised groups of 31 participants each will receive standard therapy for their primary diseases as per the local, national or international guidelines. However, participants in the intervention arm will receive additional structured yoga therapy sessions. The primary objective of this study is to assess and compare the change in fear of fall score of participants in each group using Falls Efficacy Scale (FES) and Berg Balance Scale (BBS) at 12 weeks versus baseline. The secondary endpoint will assess the change in the quality of life of participants at 3 months compared with the baseline.Data will be gathered, entered into Microsoft Excel and further analysed by R software (V.4.3.0). Changes in FES-Intervention and BBS of two groups will be compared either by Student's t-test for parametric data or Mann-Whitney U test for non-parametric data. Statistical significance will be considered if p<0.05 at 95% confidence level.

ETHICS AND DISSEMINATION: Ethical approval for this study protocol (version 1.0, 22 April 2022) was obtained from the institute ethics committee (AIIMS/IEC/22/195).

TRIAL REGISTRATION NUMBER: CTRI/2022/06/043287.